CAD - Coronary Artery DiseaseNCT03005028
Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
An observational study of CAD - Coronary Artery Disease, run by CathWorks Ltd. at 1 site in Israel.
Trial summary
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease
- How many people
- 184 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to 15 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll male and female subjects above the age of 18, with stable angina who were referred to coronary angiography and have an FFR measurement in at least one coronary artery.
Who may be able to join
- Male and female above 18 years old age which undergo FFR as part of their standard care
- TIMI Grade Flow is equal to 3
- LVEF larger than 45%.
- Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.
Who cannot join
- Contraindicated for FFR examination or adenosine administration
- STEMI
- CTO
- TIMI Grade Flow below 3
- Arteries supplying akinetic or severe hypokinetic territories
- Prior CABG on the study vessel
Show all 9Show fewer
- Left Main stenosis, In-stent restenosis and Collaterals
- Diffused atherosclerosis diseases and tandem lesions
- Aorto-ostial lesion
Trial locations and contacts
1 site in 1 country.
About this study
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.
- Conditions
- CAD - Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
Immediately following the invasive FFR procedure.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2015
- Primary completion15 Mar 2016
- Study completion15 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- CathWorks Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005028
- Sponsor's protocol ID
- FFRAngio 1.0
- Status last verified
- Feb 2018
- First submitted
- 19 Dec 2016
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pellicano M, Lavi I, De Bruyne B, Vaknin-Assa H, Assali A, Valtzer O, Lotringer Y, Weisz G, Almagor Y, Xaplanteris P, Kirtane AJ, Codner P, Leon MB, Kornowski R. Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography. Circ Cardiovasc Interv. 2017 Sep;10(9):e005259. doi: 10.1161/CIRCINTERVENTIONS.116.005259.
PubMed 28916602
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogram Based Fractional Flow Reserve FFRangio - A Validation Study
- ClinicalTrials.gov ID
- NCT03005028
- Acronym / sponsor ID
- FFRAngio 1.0
- Conditions
- CAD - Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- CathWorks Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- 15 Mar 2016 (actual)
- Study completion
- 15 Mar 2016 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the present study we aim at validating the computation of FFRangio values from the angiogram by comparing them to measured wire-based FFR values, in a larger scale and in a completely blinded manner. Investigation of a wide range of users in various conditions may strengthen the reliability of the FFRAngio measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll male and female subjects above the age of 18, with stable angina who were referred to coronary angiography and have an FFR measurement in at least one coronary artery.
Key inclusion criteria (4 listed)
- Male and female above 18 years old age which undergo FFR as part of their standard care
- TIMI Grade Flow is equal to 3
- LVEF larger than 45%.
- Subjects with multi-vessel coronary artery disease, with NSTEMI are allowed.
Key exclusion criteria (9 listed)
- Contraindicated for FFR examination or adenosine administration
- STEMI
- CTO
- TIMI Grade Flow below 3
- Arteries supplying akinetic or severe hypokinetic territories
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI
Time frame: 1 hour
Immediately following the invasive FFR procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- Derived from this study: PubMed 28916602Pellicano M, Lavi I, De Bruyne B, Vaknin-Assa H, Assali A, Valtzer O, Lotringer Y, Weisz G, Almagor Y, Xaplanteris P, Kirtane AJ, Codner P, Leon MB, Kornowski R. Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography. Circ Cardiovasc Interv. 2017 Sep;10(9):e005259. doi: 10.1161/CIRCINTERVENTIONS.116.005259.
- Individual participant dataSharing planned: No
Related trials for CAD - Coronary Artery Disease
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
Coronary Artery Disease, Coronary Artery Stenoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD - Coronary Artery Disease, run by CathWorks Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion-specific image-based FFRAngio calculation, compared to the invasive FFR as the reference gold standard, with a blinded analysis yielding Bland- Altman of +/- 15% with 95% CI (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.